Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
Reason for recall: Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery. Distribution: Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada. Quantity: 13,613 Lot/code info: UDI-DI M335400031 Plum Duo Precision IV Pump v1.2.3
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.